Senior Scientist, Combination Product Characterization (Onsite)

Job Description Senior Scientist, Combination Product Characterization Our company's Combination Product Characterization and Verification (CPCV) Team is seeking a hands-on device characterization and design focused scientist. This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company;s pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. In this role, the successful candidate will leverage a broad range of cutting-edge analytical instruments and methodologies, including in silico modeling, to develop a fundamental understanding of device material and functional properties, with a focus on pre-filled syringe and auto injector combination product development. The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. **** Our company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our company's Research Laboratories is a true scientific research facility of tomorrow and will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Education Requirement (minimum): B.S., M.S or Ph.D.. in Mechanical Engineering, Material Science or equivalent field is required. Required Experience and Skills: A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and testing/test method development experience. Solid testing and troubleshooting skills able to work independently in a laboratory setting Strong background in optical imaging and mechanical testing, including advanced imaging techniques, tensile and compression testing, surface characterization, X-ray computed tomography, rheometry, and microscopy. Excellent collaboration, ideation, and prototyping skills, including facilitating design brainstorming sessions, developing proof of concepts, working prototypes and conducting functional testing. Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis. Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA). Liaises closely with other partner functions including QA (Quality), Analytical Sciences, CROs and others to support project timelines. Cross-functional communication – communicating complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding. Development experience in risk-oriented, regulated environments Development project leadership with a proven track record collaborating with and managing external vendors/manufacturers. Preferred Experience and Skills: Experience with medical device development with understanding of Design Controls (21 CFR 820.30) Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use. Additional familiarity/experience with the following industry related knowledge is a plus: 21 CFR Part 4 21 CFR 211 FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics ISO 13485 ISO 14971 ISO 11040 ISO 10993 PSCS eligibleforERP Required Skills: Analytical Method Development, Analytical Method Development, Concept Development, Conceptualization, Creativity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Device Control, Device Design, External Partners, Failure Mode and Effects Analysis FMEA, FMECA, Geometric Dimensioning And Tolerancing (GD&T), IEC 62304, ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Medical Devices Design, Method Validation, Product Development, Product Management Leadership, Prototype Testing, Prototyping, Python (Programming Language) {+ 6 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. <p style="text-align:left"